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spECTrum EMR Software (replacement) - EUDAMED Registration 10850045508361

Access comprehensive regulatory information for spECTrum EMR Software (replacement) in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 10850045508361 and manufactured by SigmaStim Domestic LLC in United States.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class I
10850045508361
No
spECTrum EMR Software (replacement)
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12109002
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
10850045508361
Basic UDI
10850045508361DW
Version Date
January 08, 2025
Manufacturer Last Update
October 25, 2024
Active Status
No
Manufacturer
Manufacturer Name
SigmaStim Domestic LLC
Country
United States
Country Type
NON_EU
Address
19799 SW 95th Avenue TUALATIN, OREGON
Email
sigmasales@sigmastim.com
Authorized Representative
SRN
IE-AR-000006507
Country
Ireland
Address
South County Business Park Leopardstown, Dublin 18
Email
IconAR@iconplc.com
Telephone
+ 353 (1) 291 2000
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Belgium
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No